The invention describes improved methods and mechanisms for providing secure access to pharmaceutical and supply items in a clinical setting.
In large medical facilities, the main inventories of pharmaceutical items are held in storage locations which are often far removed from the patients who use them. To facilitate secure and accurate delivery of the pharmaceutical items from these storage locations to the patient, a variety of systems have been proposed and put into use. In earlier systems, referred to as a “cart exchange” system, medication carts are distributed at nursing stations in the medical facility, remote from the central pharmacy, and are periodically exchanged with fully supplied carts. Typically these carts contain a 24 hour supply of medications sorted by patient into specific drawers. The “used” cart is returned to a central pharmacy of supply area where the next 24 hours of medications are replenished. Narcotics, are stored in locked boxes on the floor, requiring two nurses with separate keys and a written log, for management.
While the cart exchange system is still in use for some medications, shorter hospital stays mean that the majority of patients are more critically ill, resulting in a changing regimen of medications throughout the day. This results in many new orders needing to be brought up from the central pharmacy during the day, and a large amount of unused medication being returned. The re-stocking of these medications needs to be done accurately, and is very time consuming. As a result there has been an increasing use of automated, processor based, cabinets on the nursing floors. The processor on each cabinet monitors the access to the pharmaceutical items in these fixed cabinets, allowing the current on hand inventory and the need for replenishment to be communicated to a central processor at the central pharmacy location. These processor based dispensing cabinets were initially used for the more convenient management of narcotics, and for the ability to have a “floor stock” of common medications from which a nurse could issue the first dose of a needed new prescription, while waiting for the 24 hours supply to come up from pharmacy in the exchange cart, or on a special order basis.
Over the last eight years or so, these processor based cabinets have expanded to offering the possibility of storing the majority of medications that the patients on the floor might need during the day and night. These medications are stored in pockets within locked drawers. In other words stocks of medications are maintained at a desired par level in non-patient specific form. This is referred to as “Floor Stock”. A nurse, upon entering their own personal ID, and the ID of a specific patient, will see the medications that are approved overall for that selected patient, referred to as “The Patient Profile”, and in some systems, will also see what medications are due at that particular time, referred to generally as “Due Medications”. The task for the central pharmacy, then, moves from selecting and filling exchange carts with a 24 hour supply of medications to each patient, to using the central processor to monitor the on-hand stock of the medications stored in the cabinets, and restocking those levels at regular intervals. A big advantage of this process is not having unused doses of medications returned to the central pharmacy. It also means that first doses (as well as subsequent doses) are immediately available.
In the final analysis, a mixture of the two systems is needed. There are still many situations that continue to require medications to be brought from central pharmacy For example, to avoid medication errors, intravenous fluids (IVs) that contain medication are now increasingly being mixed in the pharmacy and brought up to the floor for safety reasons, rather than being prepared by nurses by attaching a so-called piggy-back back medication bag, to a standard diluent bag. There are also specialized, or infrequently used medications, or those with short life, or requiring refrigeration, or that need special handling from the pharmacy. Finally there is the consideration of the time it may take nursing to select unit doses of medication at regular intervals through the day, rather than taking from a small collection of medications pre-selected by the pharmacy for a specific patient.
In addition these cabinets have provided a variety of means to only allow qualified users to have access to the cabinet, and to restrict the access of qualified users only to items to which that particular user is permitted to have access, or at least to track if users are accessing areas that are not required for the particular patient.
These cabinets also provide means to guide the user to the right pharmaceutical that is being requested, either by an indicator, which is usually a light adjacent to the pocket, or by pre-opening a locked drawer and a locked lid, the sprung lid indicating which pocket the medication of interest is in. These cabinets also provide a record of the access to that particular pharmaceutical, where that access can be detected (as is the case with the lifting of a lid that has a sensor attached).
The ideal system would only allow the user access to the single specific dose of medication requested. This is for two reasons. To ensure that only that medication is taken, as for example in the case of narcotics, where an addicted user might wish to divert extra doses for their own use. The second reason is for patient safety, to ensure that the right medication is selected. However for reasons of cost, manufacturers have provided a variety of drawers, each with different levels of restriction, and the choice is ultimately a trade off between cost, and accuracy and security.
As discussed, the ideal system would allow the user only to access the single specific dose of medication requested. In some systems, this has been provided by having metered drawers. These are drawers that have multiple doses of the same medication, but which open just enough to reveal the one, or “N” doses, requested and no more. Other systems have provided a dispenser, much like a candy or cigarette machine, that dispenses the requested medication using a rotating coil or a solenoid operated cassette, to drop just that medication into a tray that is accessible to the user's hand. A third method uses individually locking drawers, housing pockets with locked lids, each pocket containing just a single dose of a medication. These mechanisms are currently cost prohibitive for lower cost, lower security medications.
The next level of security is to use individually locking drawers, housing pockets with locked lids, each pocket containing multiple doses of a single type and dose of a medication. In accessing these medication doses, the other pockets remain locked, so the nurse is not able to take the wrong medication. They may however take the wrong quantity of the selected medication, either in error or, in the case of narcotics, for their own use. Various software systems have been provided to track the users' access and steps as much as possible, in order to track patterns of use that might indicate either erroneous access, resulting in the user taking the wrong medication, or deliberate diversion of medications. These software techniques often involve additional steps for the user. In the case of this locked pocket with multiple doses of the same medication, these software steps may include requiring that a second user be found, to act as a witness, and/or counting back the number of remaining doses in that multi-dose pocket. In the case of “count-back”, if a user finds an error—for example the quantity in the pocket is less than the processor thinks is in the pocket, which would be the number entered by the previous user in counting back—then, either the current user or the previous user has either made a mistake, or has intentionally diverted one or more doses. The problem with this approach is that taking the medication is not prevented, and analysis of the error is done later on, usually at the end of the nurses' shift, after the fact, and does not point to the specific single culprit who made an error or deliberately diverted. It requires tracking down the two parties concerned, and having at least one of them feel “wrongly accused”, and never having specific evidence. All these steps increase the time take to take the medication accurately and securely.
Another type of individually locking drawer uses multiple doses of the same medication in pockets with lids, but without locks, in order to reduce cost. The processor will monitor if a user accesses a pocket with medications that were not selected for the patient, and will record this as an incorrect access in an audit trail. But this is less desirable than a locked lid, since the access is not prevented, but entered into an audit trail in the processor, requiring someone to review the audit trail after the fact, find the culprit and discuss why they made that access, and ask if they took anything they shouldn't. A countback process can also be added with its advantages and disadvantages. It can be understood why it is preferable to prevent access in the first place.
Another type of locking drawer, referred to as a “Matrix Drawer”, opens to reveal a “matrix” of open pockets, each pocket with multiple quantities of a single medication. While the individual drawer may be locked, the security and safety issue in this case is the fact that there is no mechanism to prevent access to medications that have not been preselected in the processor for the patient, leaving open the possibility for the nurse user to take the wrong medication in error, or to take additional medications undetected.
A focus in the last five years has been the desire to use bar code checking at the point of administration at the bedside of the patient, to avoid administering the wrong medication to the wrong patient. To this end, unit doses of medication are all being bar-coded, either by the manufacturer or by the central pharmacy in packaging machine, if the medication has been bought in bulk. In some cases, checks that have evolved at the dispensing cabinets, are more appropriately done at the bedside. With the desire to have the majority of medications available in a cabinet at the nursing station, and with the increased focus on patient safety, it is the purpose of the inventions presented here, to make the cabinets more cost effective and to increase the accuracy of the dispensing process.
While the current systems provide working methods for securely issuing medications it would be desirable to reducing the potential cost of the cabinet drawers, allowing more items to be kept in more secure single dose dispensing mechanisms or single dose drawers, or that at least have more items be kept in locked and/or lidded containers, so that the processor knows that the user is accessing the correct location. In addition it would be desirable to provide mechanisms to provide better detection of, and deterrence from, diversion in drawers that allow access to multiple pockets and/or multiple doses. It would also be desirable to ensure, particularly in the case of pockets without locking lids, that the nurse is accessing the right medication, and not accessing the wrong pocket either deliberately or inadvertently, and is taking the right quantity of those medications, and to provide means to confirm to the nurse that they are taking the right medication without introducing additional steps.
In addition to the safety aspect of taking the right medication, there is also the security aspect of ensuring that the wrong medication is not deliberately taken. In many cases, the users are having to obtain narcotic items, and the pharmacy and nursing department have serious obligations to prevent diversion. It is much preferred to prevent diversion, either by having more unit doses of medication in locked pockets, or by having better deterrents to diversion. Some of this can be achieved by lowering the cost of the cabinet and so being able to cost effectively keep more narcotic items in single dose, locked pockets. But it is also desirable to have improved mechanisms and methods to record and know after the fact, what each user did at the cabinet, both to record who the user really was, in case they are using a stolen identification, and to observe and record their actions in accessing medications in the drawers themselves, and also to inform the users that their actions are being recorded on video for example, as a deterrent to them attempting to divert.
Finally, with the increasing deployment of these systems, their availability has become mission critical and it is highly desirable to increase the systems ability to aid the nurse in the dispensing process if there are any problems or questions, and to reduce the MTTR (mean time to repair) in the event of a failure.